NONA Garment Project: Noninvasive Observation of Natal Activity

描述（由申请人提供）：命名为NONA，以罗马怀孕之神命名，这一创新系统将监测准妈妈，以减轻分娩期间母亲和孩子的风险。在这个第一阶段的项目中，轨道研究公司（俄亥俄州克利夫兰）与他们在麻省理工学院、塔夫茨-新英格兰医学中心和E-Trolz公司的合作伙伴打算建立并测试一种新型的胎儿心电图（FECG）监测系统。胎儿心电图线束装置将是一个大型传感器阵列，可以方便快速地应用于准妈妈。基于服装的传感器阵列将允许传感器在一个步骤中放置在母亲的前部，后部和侧面位置。该服装将利用轨道研究公司的干式ECG记录电极、E-Trolz嵌入式平台和麻省理工学院计算生理学实验室的信号处理专业知识。提出的无创胎儿监护仪将可靠地获取胎儿心电图信号，并识别出由炎症、缺氧或缺血性损伤引起的胎儿即将损伤的特征心电图模式。在这个第一阶段的项目中，Orbital Research Inc （Cleveland, Ohio）与其在麻省理工学院、塔夫茨医疗中心和E-Trolz公司的合作伙伴将建立、测试和演示一种新型胎儿心电图（FECG）监测系统的可行性。最终项目目标（在完成第二阶段后）是生产一种可靠、廉价、无创的系统，用于妊娠和分娩期间的胎儿监测。从该系统获得的信息将减轻分娩过程中对母亲和胎儿的风险，这将显著改善临床结果，特别是高风险分娩。1个FDA批准。ORI F6T干式ECG电极适用于使用标准ECG监测电极的所有ECG监测应用。F6T电极可用于短期和长期（最长2天）心电监测。公共卫生相关性：本NONA（无创出生活动观察）项目的最终目标是：1)开发一种可靠、廉价、无创的系统用于妊娠和分娩期间的胎儿监测，2)确定预测分娩期间和产后期间不良事件的FECG特征。第一阶段的项目结果将展示整个系统的可行性——服装传感器、硬件和算法，以识别分娩过程中孩子的健康风险。在成功完成第一阶段项目后，Orbital团队将：“制造几件带有集成传感器的一次性服装”，从塔夫茨大学新英格兰医学中心的分娩中心的一组妇女那里获取数据，并“证明胎儿心率和FECG成分可以使用卡尔曼滤波相对于通过头皮传感器收集的可用真相标记物进行准确识别。”

DESCRIPTION (provided by applicant): Named NONA, after the Roman God of pregnancy this innovative system will monitor the expectant mother to mitigate the risk to mother and child during birth. During this Phase I project, Orbital Research Inc. (Cleveland, Ohio), with their partners at MIT, Tufts-New England Medical Center and E-Trolz, Inc., intends to build, then test a novel fetal electrocardiograph (FECG) monitoring system. The fetal ECG harness device will be a large sensor array that can be applied in a convenient and rapid manner to an expectant mother. The garment-based sensor array will allow sensors to be placed in anterior, posterior and lateral positions on the mother in a single step. The garment will leverage the Orbital Research dry, ECG recording electrodes1, the E-Trolz embedded platform, and signal processing expertise from the laboratory for computational physiology at MIT. The proposed non-invasive fetal monitor will reliably acquire fetal ECG signals, and identify characteristic ECG patterns that predict impending fetal injury caused by inflammatory, hypoxic, or ischemic insults. During this Phase I project, Orbital Research Inc (Cleveland, Ohio), with their partners at the Massachusetts Institute of Technology, Tufts Medical Center, and E-Trolz, Inc., will build, test and demonstrate the feasibility of a novel fetal electrocardiograph (FECG) monitoring system. The ultimate program goal (after completion of Phase II) is to produce a reliable, inexpensive, non-invasive system for fetal monitoring during pregnancy and labor. The information gained from this system will mitigate risk to the mother and fetus during delivery which will dramatically improve clinical outcomes especially from high risk deliveries. 1 FDA cleared. The ORI F6T Dry ECG Electrode is intended for use in all ECG monitoring applications where standard ECG monitoring electrodes are used. The F6T Electrode can be used in short term and long term (up to 2 days) ECG monitoring. PUBLIC HEALTH RELEVANCE: The ultimate goals of this NONA (Non-Invasive Observation of Natal Activity) program are: 1) To develop a reliable, inexpensive, non-invasive system for fetal monitoring during pregnancy and labor, and 2) to identify FECG characteristics that predict adverse events during labor and the immediate postpartum period. The Phase I program outcome will be the demonstration of the feasibility of the complete system - garment- sensors, hardware, and algorithms to identify health risk to the child during childbirth. Upon successful completion of the Phase I program, the Orbital Team will have: " fabricated several disposable garments with integrated sensors, " captured data from a set of women in the birthing center at TUFTS- New England Medical Center, and " demonstrated fetal heart rate and components of FECG can be identified accurately using Kalman Filtering relative to the available truth markers collected via the scalp sensor.